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Persyst 12 EEG Review and Analysis Software
Persyst Development Corp · Model P12 · UDI-DI 00869732000104
1
510(k) clearances
4
Adverse events
3
Recalls
13
Facilities
Description
Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-07 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this |
| 2023-02-20 | Moberg Research, Inc. | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC |
| 2020-03-05 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functi |
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